FOR IMMEDIATE RELEASE - May 10, 2013 - Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age. To date, there have been 5 complaints received, 2 of which involved serious consequences. There have been no patient deaths reported. The root cause is understood and processes have been put in place to address the issue.

This recall affects only the fifty (50) United States plus the District of Columbia. Distributors and clinical provider sites using these Symbios Medical Products have been notified of the affected product codes and lot numbers. Symbios is working to secure all affected product and have it returned. Products subject to this recall were distributed between April 1st, 2011 and April 30th, 2013. Recall action was begun immediately upon the knowledge of the product related issues.

GOPUMP / GOBLOCK KITS SUBJECT TO RECALL

Range of Affected Kit Lot #'s

Kit PN

From Kit Lot #

To Kit Lot #

Kit description

510042

11-100251

13-100128

GoPump kit 150mL, 2 mL/hr Epidural Catheter

510042-BP

12-101300

12-101300

GoPump kit 150mL, 2 mL/hr, Epidural Catheter & BIOPATCH

510080-BP

11-100215

12-100508

GoPump kit 300mL, 2 mL/hr/side, 5" Fenestrated Catheter and Biopatch

510110

11-100664

11-100664

GoPump kit 150mL, 2 mL/hr 2.5" Fenestrated Catheter

510110-BP

11-100838

12-101560

GoPump kit 150mL, 2 mL/hr 2.5" Fenestrated Catheter and Biopatch

510112-BP

11-100839

13-100225

GoPump kit 300mL, 2 mL/hr/side, 2.5" Fenestrated Catheter & BIOPATCH

510141-BP

12-100460

12-100673

GoPump kit 300mL, 2 mL/hr/side, 10" Fenestrated Catheter & BIOPATCH

510201-BP

12-100108

12-101538

GoPump kit 300mL, 2 ml/hr, 5" Fenestrated Catheter & BIOPATCH

510203-BP

12-101301

13-100611

GoPump kit 300ml, 4 ml/hr, Epidural Cath & BIOPATCH

510204

11-100505

11-100665

GoPump kit 300ml, 4 ml/hr, 2.5" Fenestrated Cath

510204-BP

11-100721

13-100680

GoPump kit 300ml, 4 ml/hr, 2.5" Fenestrated Cath & BIOPATCH

510205-BP

11-100722

13-100087

GoPump kit 300ml, 4 ml/hr, 5" Fenestrated Catheter & BIOPATCH

510349-BP

12-100935

12-100935

GoPump kit 300ml, 2 ml/hr, Epidural Catheter, 2.75" Needle, BIOPATCH

510350

11-100353

12-100233

GoPump kit 150ml, 2 ml/hr, Epidural Catheter, 2.75" Needle

510350-BP

12-100429

13-100047

GoPump kit 150ml, 2 ml/hr, Epidural Catheter, 2.75" Needle, BIOPATCH

510401-BP

12-101045

12-101540

GoPump kit 300mL, 2 mL/hr/side, 7.5" Catheters, BIOPATCH

510458

11-100618

13-100703

GOBlock Kit 600 ml, 10 ml/hr

510462-BP

11-100694

13-100092

GoPump kit 600mL, 2 mL/hr/side, 5" Catheter, BIOPATCH

510472

11-100385

13-100354

GOBlock Kit 600 ml, 8 ml/hr

510491

11-100601

13-100705

GOBlock Kit 600 ml, 6 ml/hr

510545-BP

11-100718

13-100229

GoPump kit 300mL, 2 mL/hr/side, 5" Fenestrated Catheter, BIOPATCH

510551-BP

11-100500

13-100672

GoPump kit 300mL, 4 ml/hr, 2.5" Catheter, 2.75" Needle, BIOPATCH

510556-BP

11-100779

12-101552

GoPump kit 150ml, 2 ml/hr, 2.5" Catheter with 2.75" Needle, BIOPATCH

510558-BP

12-100403

12-101343

GoPump kit 600mL, 2 mL/hr/side, 10" Catheter, 6" needle, BIOPATCH

510608

11-100695

12-101544

GOBlock kit 300mL, 4 ml/hr

510611

11-100302

13-100227

GOBlock Kit 300ml, 4 ml/hr

510612

11-100817

12-101475

GOBlock Kit 300ml, 6 ml/hr

510642

12-100616

13-100590

GoPump kit 300mL, 2 ml/hr

510643

12-100332

13-100183

GoPump kit 600mL, 2 mL/hr/side

510646

11-100632

12-101233

GoPump kit 600mL, SF

510644

11-100565

13-100169

GoPump kit 300mL, 2 ml/hr per side

510654

11-100833

13-100174

GOPump kit 150mL, 2 ml/hr

Consumers or using customer sites with questions may contact the company via telephone at 317-225-4447 ext 25 between the hours of 8:00am and 4:00pm.EST. Customers may also contact the company via e-mail at jcarty@symbiosmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:

Symbios Medical Products is committed to the highest level of product quality and fully regrets the most recent product related issues. The Board of Directors of Symbios and its Management Team are constantly reviewing our programs and processes for product requirements and quality of our product in support of pain control of our customer’s patients. The expanse of this action is indicative of our desire to insure safe and effective product availability.